Medical treatment system and method of use

ABSTRACT

A medical treatment system including a treatment chamber, a source of an aqueous mist containing a medication, a source of an oxygen-enriched gas, and a control system adapted to alternately surround a human body part with a mist containing a medication and the oxygen enriched gas, which can be used to treat various skin disorders including infected lesions, bacterial infections such as acne (i.e.  Propionibacterium acnes ), fungal infections such as Athelete&#39;s foot (i.e. fungal genus  Trichophyton ), conditions associated with hair loss including alopecia as well as ulcerations and frostbite resulting from poor circulation. A method of treating skin disorders is also disclosed, that includes providing a mist containing a medication and enriched oxygen gas to the site being treated as well as providing oxygen to the patient during treatment.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57, forexample, this application is a U.S. National Phase Application of PCTInternational Application Number PCT/US2013/048801, filed on Jun. 29,2013, designating the United States of America and published in theEnglish language. The disclosure of the above-referenced application ishereby expressly incorporated by reference in its entirety.

RELATED APPLICATION

None

TECHNICAL FIELD

The present disclosure relates in general to medical treatment systems.More particularly, the present disclosure relates to a medical treatmentapparatus, methods of using the medical treatment apparatus and a systemfor treatment of medical conditions including bacterial and fungalinfections, hair loss and surface wounds.

BACKGROUND

Medical professionals and healthcare providers such as nurses anddoctors routinely treat patients having various skin disorders includinginfected lesions, bacterial infections such as acne (i.e.Propionibacterium acnes), fungal infections such as Athelete's foot(i.e. fungal genus Trichophyton), conditions associated with hair lossincluding alopecia areata (patch baldness), alopecia totalis (completebaldness of the scalp) and alopecia universalis (body baldness) as wellas ulcerations and frostbite resulting from poor circulation. Variationsin skin disorders and other patient indications dictate variations indesired medications for treatment, such as antibiotics, growth factors,enzymes, hormones, protocols, such as delivery rates for medication andtemperature control.

A vast majority of bacteria are harmless or beneficial. However, thereare a few that are pathogenic. One such bacteria, Propionibacteriumacnes causes acne vulgaris that is painful, causing seborrhea (scaly redskin), comedone (blackheads and whiteheads) and pimples often resultingin scarring and in extreme cases disfigurement. It is estimated thatnearly 85% of people between the ages of 12 to 24 develop acne. Youngmen are more likely to suffer the effects of acne for longer periods oftime then Young women because testosterone tends to make acne worse. In2013, it was estimated that there were over 316 million people in theUnited States and approximately one third of those individuals werebetween the ages of 10 and 24. With close to 100 million suffering fromacne in the US alone the skin care industry for the past fifty or soyears has been developing treatments with limited success. Currently,most medications include one or more of the following chemicals: benzoylperoxide, salicylic acid, glycolic acid, sulfur and azelaic acid.However, because most individuals skin is unique it is difficult to findthe appropriate formulation that will relieve or eliminate acne.Consequently, many individuals do not obtain proper treatment and areleft to suffer with acne and often have scaring as a result. The needfor a proper treatment is evidenced by individuals spending over 78billion dollars on skin care worldwide in 2010 with facial carecapturing 64% of this market.

Athelete's foot also known as Tinea pedis is an inflammatory conditionand represents the most common of all superficial fungal skininfections. Over 1 million individuals in the United States contractAthlete's foot each year. It is predominantly caused by a group of fungicalled dermatophytes which includes Trichophyton rubrum, Trichophytonmentogrophytes var. interdigitale and Epidermophyton floccosum. For mostpatients, recurrent or chronic foot fungal infections are more of aninconvenience than a problem. Rarely is treatment sought. This mayexplain the high prevalence of the disease. Cellulitis is a more seriousconsequence of an untreated fungal foot infection. Although treatable,it can be a limb-threatening disease for patients with comorbidities.Individuals with diabetes have an increased risk of developing thiscomplication. The frequent outcome for this group is hospitalization andan increased length of stay when compared to their non-diabeticcounterparts.

There are three main groups of topical agents for treating fungal skininfections, allylamines (i.e. terbinafine), imidazoles (i.e.clotrimazole, ketoconazole, sulconazole and miconazole) and morpholinederivatives (i.e. amorolfine). All have been demonstrated to be moreeffective than placebo. However, their speed of action varies makingcompliance difficult and often resulting in ineffective treatment.

Alopecia, or hair loss, effects approximately 35 million men and 21million women in the United States. Alopecia areata is a disorder thatcauses sudden hair loss on the scalp and other regions of the body. Itaffects more than 5 million Americans, 60% of them under the age of 20.It is not a health threat, but can be psychologically damaging,especially for children, to cope with baldness. Of men being treated forAlopecia approximately 85% are being treated with Minoxidil andapproximately 15% are being treated with Finasteride. Minoxidil, morecommonly known as Rogaine is a nonprescription medication approved forandrogenetic alopecia and alopecia areata. In a liquid or foam, it isrubbed into the scalp twice a day. This is the most effective method totreat male-pattern and female-pattern hair loss. However, only 30-40% ofpatients experience hair growth and it is not effective for other causesof hair loss. Hair regrowth can take 8 to 12 months and treatment mustbe continued indefinitely because hair loss resumes if treatment isstopped. Finasteride (Propecia) is used in male-pattern hair loss in apill form taken on a daily basis. It is not indicated for women and isnot recommended in pregnant women. Treatment is effective within six toeight months of treatment. Side effects include decreased libido,erectile dysfunction, ejaculatory dysfunction, gynecomastia, andmyopathy. Treatment should be continued as long as positive resultsoccur. Once treatment is stopped, hair loss resumes again. In 2013, itis anticipated that men will spend over $225 million on medicinaltherapies like Rogaine. Unfortunately, the low percentage of success,potential side effects and lifetime treatment regimen make this optiondifficult for many individuals.

Another particular area of concern involves foot or limb wounds indiabetic patients. It is known that foot wounds in diabetic patientsrepresent a significant public health problem throughout the world.Diabetes is a large and growing problem in the United States andworldwide, costing an estimated $45 billion dollars to the U.S. healthcare system. Patients afflicted with diabetes often have elevatedglucose and lipid levels due to inconsistent use of insulin, which canresult in a damaged circulatory system and high cholesterol levels.Often, these conditions are accompanied by deteriorating sensation inthe nerves of the foot. As a result, diabetics experience a high numberof non-healing foot ulcers.

It is estimated that each year up to three million leg ulcers occur inpatients in the U.S., including venous stasis ulcers, diabetic ulcers,ischemic leg ulcers, and pressure ulcers. The national cost of chronicwounds is estimated at $6 billion. Diabetic ulcers often progress toinfections, osteomyelitis and gangrene, subsequently resulting in toeamputations, leg amputations, and death. In 1995, approximately 70,000such amputations were performed at a cost of $23,000 per toe and $40,000per limb. Many of these patients progress to multiple toe amputationsand contralateral limb amputations. In addition, the patients are alsoat a greatly increased risk of heart disease and kidney failure fromarteriosclerosis which attacks the entire circulatory system.

The conventional methods of treatment for non-healing diabetic ulcersinclude wound dressings of various types, antibiotics, wound healinggrowth factors, skin grafting including tissue engineered grafts, use ofwheelchairs and crutches to remove mechanical pressure, and finallyamputation. In the case of ischemic ulcers, surgical revascularizationprocedures via autografts and allografts and surgical laserrevascularization have been applied with short term success, but withdisappointing long term success due to reclogging of the grafts. In thetreatment of patients with venous stasis ulcers and severe venousdisease, antibiotics and thrombolytic anticoagulant and anti-aggregationdrugs are often indicated. The failure to heal and the frequentrecurrence of these ulcers points to the lack of success of theseconventional methods. Accordingly, the medical community has a criticalneed for a low cost, portable, non-invasive method of treating diabetic,venous, ischemic and pressure ulcers to reduce mortality and morbidityand reduce the excessive costs to the health care system.

Most problematic of all is that treatment of diabetic foot ulcers hasbeen focused on amputation and not on limb salvage, as many of thewounds have not been properly treated. Improper treatment can beattributed to lack of an easy and inexpensive treatment system andmethod and severe inconvenience to the patient in using current methods.There is a need to prevent amputation by healing such wounds,particularly at an early stage.

Furthermore, amputation for conditions such as foot ulcers and frostbitebecomes less avoidable the longer the condition is either left untreatedor is unsuccessfully treated. Therefore, it is crucial to apply aneffective treatment regimen as soon as possible. Unfortunately, footwounds in patients with, for example, diabetes develop because of aprocess called neuropathy. Diabetes causes loss of sensation such thatskin injury and complete breakdown (ulcer) can develop with no orminimal pain. These wounds tend not to heal because of ongoingmechanical trauma not felt at all by the patient as painful. Therefore,by the time the patient discovers the wound, the wound has oftenprogressed so that the patient's treatment options have become severelylimited.

In many cases, such wounds can only be healed by protecting them frommechanical trauma. Small plantar ulcers in diabetic patients areausually seen by primary care practitioners and endocrinologists. Thepresent method for healing plantar ulcers is a total contact cast forthe foot, which provides complete mechanical protection. This method isnot ideally suited for either of these practice settings, because itrequires skilled and specialized care in application, along withfrequent follow up. Most patients perceive the cast to be aninconvenience at the early stages of such a wound, while perceiving thatsuch a wound is not a serious matter. The alternative to the cast is toask the patient to be non-weight bearing through the use of awheelchair, crutches, or a walker, which provide complete mechanicalprotection only with complete patient compliance. This alternativerarely proves to be effective in healing wounds within a reasonable timeperiod.

What is needed is a treatment that primary care physicians and theirstaff can employ to treat bacterial and fungal skin infections, hairloss, skin ulcers and other wounds that do not require extendedphysician time and that is effective even at later stages of the medicalcondition. Also, what is needed is a treatment that allows patients tobe able to continue their active lives without the need to wear casts,or be confined to wheelchairs and crutches.

SUMMARY

In one embodiment, a wound treatment apparatus includes a treatmentvessel having a treatment chamber and an opening to the treatmentchamber that are sized to receive a human limb. A removable andsubstantially gas impermeable liner lines the chamber of the vessel andforms a treatment zone around the patient's limb. A cuff is removablycoupled to the opening of the vessel and is sized to sealingly engage ahuman limb when the limb is inserted through the opening. A mixture tankholds a humidifying agent and is in fluid communication with the chamberof the vessel. A first array of light emitting diodes is coupled to thechamber and emits ultraviolet light into the chamber. A speaker isattached to the vessel and delivers low frequency sound waves to thechamber. A second array of light emitting diodes is coupled to thechamber and emits pulsed light into the chamber.

A wound treatment system includes a vessel that is sized to receive ahuman limb. The vessel includes a chamber with an opening leading intothe chamber. A removable liner lines the chamber of the vessel and formsa treatment zone. A humidifier in fluid communication with the treatmentzone humidifies a solution of water and antibacterial agent. An oxygensource is in fluid communication with the treatment zone. A speaker iscoupled to the vessel and emits low frequency sound waves to thechamber. A first array of light emitting diodes that emits ultravioletlight is coupled to the vessel near the opening of the treatmentchamber. A second array of light emitting diodes that emits pulsed lightinto the chamber is coupled to the chamber. The system also includes acontrol panel.

A wound treatment method for treating a wounded limb is also described.The method includes cleaning the wound. The method also includesdisinfecting the limb by passing the limb through a ring of ultravioletlight emitting diodes that emit ultraviolet light on the limb as thelimb passes through the ring. The limb is placed into a vessel having achamber that is lined, with a substantially gas impermeable liner bypassing the limb through a cuff that sealingly surrounds a portion ofthe limb, thus forming a substantially gas impermeable treatment zonearound a portion of the limb distal the cuff. The limb is heated byintroducing warm water into the chamber, which causes the inner liner tocollapse around the patient's limb. The warm water is emptied out of thechamber, and a temperature controlled mist of topical hyperbaric oxygen,water and an antibacterial solution is introduced into the treatmentzone. The limb is massaged by activating a speaker coupled to the vesselthat transmits low frequency sound waves to the treatment zone. The limbis heated and kept warm by activating an array of light emitting diodescoupled to the vessel that emits pulsed light onto the limb.

In another aspect, a method for treating an individual having a medicalcondition or an infection is provided. The method comprises the steps of(a) introducing a body part of an individual having a medical conditionor infection into a treatment chamber; (b) surrounding the body part inthe treatment chamber with a mist containing water and a medication; and(c) surrounding the body part in the treatment chamber with anO₂-enriched gas without increasing the pressure around the body part to22 mm Hg.

The medical condition may be acne vulgaris resulting from infection byPropionibacterium acnes or Athlete's foot caused by a group of fungi ofthe genus Trichophyton. The body part may be the face or an appendage.More specifically, a hand, a forearm, a hand and forearm, a hand,forearm and upper arm, a foot, a calf, a foot and calf or a foot, calfand thigh.

The medications may be general such as betadine, isopropyl alcohol,bacitracin, hydrogen peroxide, and combinations thereof. Alternatively,they may be specific for the infection, such as benzoyl peroxide,salicylic acid, glycolic acid, sulfur, azelaic acid or combinationsthereof for the treatment of acne or6-piperidin-1-ylpyrimidine-2,4-diamine 3-oxide (Minoxidil),N-(1,1-dimethylethyl)-3-oxo-(5α,17β)-4-azaandrost-1-ene-17-carboxamide(Finasteride),(11β,16α)-9-fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione(Triamcinolone),17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid,γ-lactone acetate (Spironolactone) or combinations thereof for thetreatment of Athlete's foot.

The treatment zone may receive an adiabatic mist comprised of water orwater mixed with medication. This treatment may be followed bydisplacing the mist with oxygen-enriched gas. Alternatively, the gas maybe pure oxygen. This process may be performed multiple times in a singletreatment. Under one treatment method steps b and c are repeated fourtimes in one treatment lasting 80 minutes.

The one or more chambers may also be flooded with either one or bothultraviolet light and/or infrared light during treatment.

In yet another aspect, a variable hyperoxia treatment apparatus isprovided that includes one or more treatment chambers being sized toreceive a human body part. A removable and substantially gas impermeableliner that lines each of said chambers and forms a treatment zone aroundthe human body part. A mixture tank holds a humidifying agent and has amedicinal filling port for receiving medications to be mixed with thehumidifying agent. The mixture tank is in fluid communication with thegas impermeable liners. The oxygen concentrator concentrates O₂ from theenvironment and is provided with an O₂ dispensing port in gas tightcommunication with the gas impermeable liners. The one or more treatmentchambers having an inlet port for receiving fluid and an outlet port fordispensing the fluid.

In one configuration of the variable hyperoxia treatment apparatus, theelectric components and mixture tank are separated from the oxygenconcentrator and oxygen receiving port by the one or more treatmentchambers. Alternatively, the oxygen components are housed in a containerseparated from the electric components. In addition, the variablehyperoxia treatment apparatus may further comprise a variety of otherfunctional components. For example, the variable hyperoxia treatmentapparatus may include a fluid connection between the humidifier and themixture tank; an oxygen control valve; a pump that pumps water intoand/or out of the one or more chambers; a cuff removably coupled to theopening of the one or more treatment chambers and sized to sealinglyengage a human body part; a nasal cannula and/or facemask incommunication with said oxygen concentrator for administering oxygen toan individual during treatment; a speaker that delivers low frequencysound waves to the one or more chambers when they contain water;ultraviolet and/or infrared light emitting diodes to illuminate thesurface of the human body part; or a variety of sensors in fluidcommunication with the treatment zone such as a temperature sensor; ahumidity sensor and/or a pressure sensor.

The liner is made of a sterile or sterilizable plastic material and mayfurther comprise a pressure release valve fluidly connecting thetreatment zone with the one or more chambers; or one-way valves in fluidconnection with the mixture tank and/or oxygen concentrator.

In other embodiments of this aspect of the invention, the cuff may bemade of an open cell material configured to naturally leak fluid forminga baffle for the treatment zone.

In still another aspect of the invention, a variable hyperoxia therapytreatment system is provided with a control panel for operating thesystem. One or more treatment chambers are provided, each having atleast one opening and sized to receive a human body part. A removableand substantially gas impermeable liner lines each of the chambers andforms a treatment zone around the human body part. A humidifier createsa mist from a solution of water that may include one or more medicationsand an oxygen source are both in fluid communication with the treatmentzone. The oxygen received by the treatment zone may be provided by anoutside oxygen source such as an oxygen tank or may be provided throughthe oxygen concentrator.

The control panel comprises a master power switch and may be operatedmanually or automatically according to a predetermined regimen. Ifoperated automatically, a plurality of automatic settings correspondingto a plurality of predetermined regimens may be utilized.

In one embodiment of this aspect of the invention, one or more treatmentchambers may be affixed securely to a human body part. Alternatively, ahuman body part may be inserted into one or more chambers for treatment.In addition, the system may further comprise a fluid source for fillingthe one or more chambers with fluid.

In another embodiment of this aspect of the invention, the variablehyperoxia therapy treatment system may further comprise an adiabatichumidifier; an ultrasonic energy source to form a mist from a solutionof water that may include one or more medications; an oximeter; an O₂concentrator; a wireless transmitter adapted to transmit data; a barcodedata reader and/or a sensor in communication with a foam cuff thatdetermines the position of the cuff when fitted about the human bodypart. The position establishes a volume range of humidified solutioncontaining one or more medications to be dispensed into the liner fortreatment of the body part.

Other aspects of the invention are found throughout the specification.

DESCRIPTION OF DRAWINGS

These and other features and advantages will be apparent from thefollowing more particular description thereof, presented in conjunctionwith the following drawings, wherein:

FIG. 1 is a three-dimensional view of a wound treatment system.

FIG. 2 is a is an illustration of a control panel of a wound treatmentsystem.

FIG. 3A is another three-dimensional view of the wound treatment systemdepicted in FIG. 1.

FIG. 3B is a three dimensional view of the wound treatment systemdepicted in FIG. 1 with patient being treated.

FIG. 4A is a three dimensional view of a lid assembly of a woundtreatment system.

FIG. 4B is a three dimensional view of a treatment vessel of a woundtreatment system.

FIG. 5 is a side exploded view of a treatment vessel of a woundtreatment system.

FIG. 6A is a front transparency view of the treatment vessel depicted inFIG. 5.

FIG. 6B is a top view of the wound treatment tank depicted in FIG. 5.

FIG. 7A is a front transparency view of a wound treatment chamber.

FIG. 7B is a bottom view of the wound treatment chamber depicted in FIG.7B.

FIG. 8A is a rear view of a wound treatment system with a rear panelremoved.

FIG. 8B is another rear view of the wound treatment system depicted inFIG. 8B further depicting a humidifier.

FIG. 9A is a front transparency view of a water reservoir used in awound treatment system.

FIG. 9B is a side transparency view of the water reservoir depicted inFIG. 9A.

FIG. 10 is a side transparency view of one aspect of the variablehyperoxia therapy treatment system showing separation of the electricalcomponents from the components that receive and dispense oxygen, anoxygen concentrator for collecting and administering oxygen to the linerand/or patient during treatment and the liner with separate openings andone-way valves for receiving mist from the humidifier and oxygen fromthe oxygen concentrator.

FIG. 11 shows optional adapters that may be connected to the variablehyperoxia therapy treatment system in FIG. 10 to treat areas of the bodythat cannot be inserted into the central chamber of the device such asthe back and scalp.

DETAILED DESCRIPTION

The apparatus, systems, and methods described herein provide hyperbaricoxygen to open, chronic wounds as an adjunct therapy in wound managementand treatment. In addition, per determination by the healthcareproviders that use the described apparatus, systems, and methods, theycan also provide mild heat, gentle massage, infrared and ultravioletlight therapy, moisture therapy, and application of antibacterialagents. These features are intended to promote the rate of healing andsuppression of bacterial growth.

Turning to FIG. 1, a wound treatment system 10 is shown, which generallyincludes a topical oxygen chamber for limbs and is intended to surrounda patient's limb and apply humidified water, antibacterial agent, andoxygen topically at a pressure slightly greater than atmosphericpressure. The wound treatment system 10 includes a rectangular, rigidplastic carriage 15 having a treatment vessel 800 forming a chamber 810(shown in FIG. 5) that is sized to accommodate a patient's limb,particularly a patient's foot and a portion of the leg up to the knee. Apadded leg rest 18 supports the patient's leg during treatment sessions.The system also includes a control panel 30, a cart 40 housing a firstreservoir 600 for water, an adiabatic humidifier 400 that holds asolution of water and antibacterial agent, a water pump 500 (all shownin FIGS. 8A and 8B), and a control box (beneath the control panel) thathouses the circuit boards that control the system 10. A mist controlvalve unit 50 is attached to a back panel of the cart 40. A hose 70connects the mist control valve unit 50 to the vessel 20, and one ormore hoses 71 connect the humidifier 400 to the mist control valve unit50.

Covering the vessel 800 is a lid assembly 60 (shown in FIGS. 1 and 4A)that includes a first lower lid 61 that is hinged to the vessel 800 atthe proximal end 64 of the vessel 800 opposite the end abutting the backpanel of the cart 40. The lower lid 61 includes a circular opening 161that provides access to a chamber 810 formed inside the vessel.

The lid assembly 60, as shown in FIGS. 1 and 4A, also includes a secondupper lid that is formed by two opposing covers 62 and 63. Cover 62covers the distal side 64 of the vessel 800 and cover 63 covers theproximal side 65 of the vessel 800. The covers 62 and 63 are completelyremovable from the top of the vessel 800. The distal side of cover 63forms a half circular indentation that is matched by a half circularindentation in the proximal side of cover 62 so that when the distalside of cover 63 and the proximal side of cover 62 join, a round opening169 is formed when the covers 62 and 63 are secured over lid 61. Eachcover 62 and 63 has a raised half circular wall 67 and 68 projectingvertically from its top surface around its corresponding half circularindentation. When the covers are joined as shown in FIG. 1, the walls 67and 68 join to form a cylinder 69. The round opening 169 formed when thehalf circular indentations are joined is concentric with the circularopening 161 of the lower lid 61 so that a patient's limb can projectdown through the cylinder 69, through opening 169 formed by the covers62 and 63, through opening 161 of the lower lid 61, and into the chamber830 of the vessel 20.

An oxygen inlet port 77 on the cover 62 (or alternatively cover 63)receives a hose 78 connected to an oxygen source, such as an oxygen tankor a central oxygen source in a hospital. The inlet port 77 can includea fitting (not shown) to sealingly secure the hose 78 to the cover 62.The cover 62 includes a vapor inlet port 72 that receives the hose 70.The vapor inlet port 72 can include a fitting 73 to sealingly secure thehose 70 to the vapor inlet port 72. Either of the covers 62 or 63 canalso include a temperature sensor 92, a humidity sensor 94, and apressure sensor 96, each of which are in fluid communication with atreatment zone formed by a treatment bag 100 sealed to the lid 61 of thevessel (FIG. 4B). The cart 40 includes wheels 41 at each corner tomobilize the system 10.

As shown in FIG. 2, the control panel 30 includes a display with variousknobs and switches that controls the operation of the wound treatmentsystem 10. The panel includes controls 130 that control the humidifier,controls 140 that control an array of ultraviolet light emitting diodes(LEDs) 310 (see FIGS. 4A and 4B) controls 150 that control an array orboard of infrared light 880 (see FIGS. 4B, 6A, and 7A) and an audiotransducer or speaker 870 (see FIGS. 5, 6A, 7A, and 7B), controls 160that control a water pump 500 (see FIG. 8A), and controls 170 thatcontrol the master power for the system 10.

The humidifier functions of the system are controlled by controls 130,which include at least some of the following: an on/off switch 131 thatturns on the humidifier function; a button 132 that can be used tomanually activate or open the mist control valve unit 50 and thatilluminates when the mist control valve unit 50 is open and allowing theflow of therapeutic mist into the chamber 830; a button 133 that opensan electronic oxygen flow valve in the tubing 78 connected to the oxygensource and illuminates when the oxygen flow valve is open and allowingoxygen flow into the chamber 810; an auto/manual switch 134 that setsthe humidifier function to either manual operation or auto operation; amist timer knob 135 that is used to set the amount of time for mist flowinto the chamber 810; and an oxygen timer knob 136 that sets the amountof time for oxygen flow into the chamber 810.

The UV functions of the system is controlled by controls 140, whichinclude at least some of the following: an on/off switch 141 that turnson the UV function; a foot in button 142 that illuminates when thepatient inserts his foot through the opening 169—the collar 300 can havea sensor 360 that senses the foot and sends a signal back to the controlbox to activate the UV LEDS; a UV on button 143 that can be depressed tomanually activate the UV LEDS 310 and that illuminates when the UV LEDS310 are activated; an auto/manual switch 144 that sets the UV functionto either manual operation or auto operation; and an UV timer knob 145that sets the amount of time that the UV LEDS will remain on once theyare activated.

The IR/Audio functions of the system is controlled by controls 150,which include at least some of the following: an on/off switch 151 thatturns on the IR/Audio function; an IR button 152 that can be used tomanually activate the IR LEDS and that illuminates when the IR LEDS andspeaker are operating; an Audio, button 153 that can be used to manuallyactivate the speaker or audio transducer and that illuminates when thespeaker is operating; an auto/manual switch 154 that sets the IR/Audiofunction to either manual operation or auto operation; and a timer knob155 that sets the amount of time that the IR LEDS and speaker willremain on once they are activated.

The pump control functions of the system is controlled by controls 160,which include at least some of the following: an an/off switch 161 thatturns on the pump control function; a drain button 162 that can be usedto manually operate the timing of drainage of the chamber 810 and thatilluminates when the chamber 810 is draining; a fill button 163 that canbe used to manually operate the timing of filling the chamber 810 withwarm water and that illuminates when the chamber is filling with water;and an auto/manual switch 164 that sets the pump control function toeither manual operation or auto operation.

The master control buttons 170 include at least some of the following: amaster control switch 171 that turns the system on and off; a startbutton 171 that is used to start the operation of the system and thatilluminates when the system is operating; and a stop button 172 that canbe depressed to prematurely stop the operation of the system.

In one embodiment, the control panel 30 also includes a thermostat (notshown) that is electrically coupled to a submergible water heater 680(see FIG. 9A) that is located in the water reservoir tank 600. Thethermostat can be used to control the temperature of the water that ispumped from the water reservoir tank 600 into the chamber 810.

In operation, the system 10 works by switching the master power switch170 to the on position, which turns the system on and puts the system inready mode. The healthcare provider then decides which of the functionswill be used in the specific regimen for the particular patient.Depending on the patient and the ailment, the regimen may provide foroperation of all of the functions, or just some of the functions. Forexample, a regimen may call for warming the limb with injection of warmwater into the chamber and then treating the wound with the antibioticmist, but may not require infrared treatment and low frequency soundvibrations. Thus, all of the on/off switches would be switched to theone position except for the IR/Audio control switch 151, which wouldremain in the off position. When operating under normal conditions, allof the functions can be turned on by switching all of the on/offswitches to the on position. This sets all of the functions to readymode. The mist timer knob 135 and oxygen timer knob 136 can then be setto operate for the appropriate amount of time. According to oneembodiment, the mist can be set at about fifteen minutes, while theoxygen is set at about five minutes. The UV timer knob 145 is set tooperate for an appropriate amount of time. According to one embodiment,the UV timer is set to operate for less than 5 seconds, less than 4seconds, less than 3 seconds, less than 2 seconds, or less than 1second. The IR/Audio timer can be set to operate for a period of timecoinciding with the warm water bath of the limb, which is when thechamber is filled with warm water, which warms the limb. This period canlast from about one minute to about ten minutes or more. All of theauto/manual switches can be set to auto for a predetermined and defaultregimen. Next the healthcare provider depresses the start button 171,which begins the regimen.

According to one embodiment, when all of the functions are in operationand auto modes, and the start button 171 is depressed, the systemoperates as follows. First the system waits for the sensor 360 to detectthe insertion of a limb of a patient P, as shown in FIG. 3B) into thechamber 810. After the wound in the limb is cleaned, the limb isinserted through the opening 169 of the covers 62 and 63 and the opening161 of the lid 61. The sensor 360 detects the limb as it passes throughthe opening 161 and activates the UV function, which activates the ringof UV LEDs 310 located concentrically around the opening 161. The UVLEDS 310 briefly stimulate the limb (about one to five seconds) as itpasses through the opening of the chamber 810 and then the UV LEDs 310deactivate. The UV on button 143 illuminates while the UV LEDs are on.

Next, a cuff 90 is placed around the limb and the lids 62 and 63 closedaround the cuff 90 so that the half circular walls 67 and 68 form asubstantial seal around the cuff. The cuff will be discussed in moredetail later. The limb is placed in a bag or liner 100 that issubstantially impermeable to gas. The top opening of the bag 100 issealed to the bottom surface of the lid 61 and forms an airtight sealwith the bottom surface of the lid 61. Thus, when the limb is surroundedby the cuff 90, which is surrounded by the half circular walls 67 and68, the portion of the limb distal the cuff is inside the bag in asubstantially sealed treatment zone.

Once the limb is secured as described, the pump 500 is activated andpumps warm water from the water reservoir 600 to the chamber 810 of thevessel 800 through a hose 510 that is connected to an outlet port 660 inthe reservoir 600 on one end and the pump 500 on the other end. Anotherhose 520 carries the water from the pump 500 to a water pipe protrudingfrom the vessel 20 that is connected to an opening in the chamber 810.The water pump 500 shuts off automatically after a predetermined amountof water is drained from the reservoir 600. The warm water entering thechamber 810 causes the bag 100 to collapse around the limb and creates awarm southing sensation on the limb. The warm water bath remains in thechamber 810 for a predetermined amount of time, generally between aboutone minute and ten minutes or more. The array of IR LEDs 880 in thechamber 810 is activated and transmits a pulsed (or steady) IR lightduring the warm water bath. The IR LEDS further warm the limb increasingcirculation.

Also contemporaneous with the activation with the IR LEDs 880, the audiotransducer or speaker 870 is activated and generates a low frequencysound wave that surrounds the limb. This creates a massaging effect,stimulates the skin and further enhances circulation. The water pump 500is then activated in reverse and the warm water is pumped out of thechamber 810 and back into the reservoir 600. The IR LEDs 880 and theaudio transducer 870 are turned off.

An adiabatically-humidified, temperature-controlled vapor of water and atopical antibacterial, antiseptic or antibiotic agent is released fromthe humidifier 400 by mist control valve unit 50. The vapor travelsthrough the tube 70 and, enters the treatment zone through a port 72 inthe lid 62, which is substantially sealed to the tube 70. The vaporhydrates the wound and provides antibacterial effects. This vaportreatment can last between about two minutes and about thirty minutes,depending on the timer 135 set by the healthcare provider. In oneembodiment, vapor treatment lasts about fifteen minutes. Then the mistcontrol valve unit 50 is activated to close the valve between thehumidifier 400 and the tube 70.

At this time, the oxygen release valve is opened and oxygen flows fromthe oxygen source, which can either be an oxygen tank as shown or a wallmounted oxygen unit connected to a central oxygen source, such as in ahospital setting (not shown). The oxygen flows through the tube 78 intoan oxygen inlet port 77 on the surface of the lid 62. The oxygendisplaces the vapor and oxygenates the wound. Oxygenation can lastbetween about one minute and about fifteen minutes. In one embodiment,oxygenation lasts about five minutes. The process between vaportreatment and oxygenation can be repeated several times. In oneembodiment, vapor treatment and oxygenation are repeated three times fora total of four rounds of treatment lasting approximately eightyminutes. The patient's oxygen level can be monitored during treatmentusing an oximeter connected to the patients finger or other body part.The oximeter can be electrically connected to the control circuits inthe control box of the system 10, and a display can warn the user tostop treatment or introduction of oxygen if the patient's blood oxygenlevel is too low or too high according to a predetermined level, such asbelow 80% saturation for an extended period of time. An extended periodof time can be two or more minutes.

FIG. 3A shows the wound treatment system 10 with the control panel 30lid removed and the lid 61 opened. Underneath the lid of the controlpanel reside the various electronics and circuitry of the system 10. A12V power supply 220 can be used to power the system. A sweep functiongenerator 210 is used to generate a low frequency waveform for the audiofunction. The sweep function generator 210 can generate an adjustablefrequency of between about 1 Hz and about 1000 Hz. It can generatevarious types of waveforms, such as sweeping waveforms and rampingwaveforms within that range of frequencies. The sweep function generator210 produces a sin wave signal that is transmitted to the audioamplifier 230, which can be a 12V amplifier. The amplifier 230amplifies, the signal to about 50 W and transmits the amplified signalto the speaker or audio transducer 870 connected to the vessel 800. Thesweep function generator 220 can be preset to a default frequency andwaveform. In one embodiment, it can be preset to generate a 60 Hzsignal, which can be manually altered to produce a signal at otherfrequencies between the range of about 1 Hz and about 1000 Hz. Anassembly control cable 240 connects the control box (not shown) with theelectronic components of the system. The control box (not shown), whichis housed underneath the control panel lid 30, houses all of the circuitboards required to operate the system 10.

In one embodiment, as shown in FIGS. 3A and 4B, on the bottom surface61B of the lid 61 is a circular collar 300 that forms a perimeter aroundthe opening 161 on the bottom surface 61B of the lid 61. An array of UVLEDs 310 is mounted on the inner surface of the collar forming a ring.The UV LEDs 310 each point toward the center of the opening 161. Therecan be as few as four LEDS and as many as one hundred twenty or moreLEDs in the array of UV LEDs 310. The array of UV LEDs 310 can deliver330 W of UVA at about 320 nm to about 400 nm. Alternatively, or inaddition to, the array of UV LEDs 310 can deliver 330 W of UVB at about290 nm to about 320 nm. Alternatively, or in addition to, the array ofUV LEDs 310 can deliver 330 W of UVC at about 100 nm to about 200 nm. Inone embodiment, there are ninety UV LEDs delivering 330 W of UVA atabout 374 nm to about 392 nm, delivering a total of about 324 mW or 324W. The collar 300 also includes a motion sensor 360 to detect when alimb has been inserted through the collar and the ring of UV LEDs 310.The motion sensor is connected to the control box through a wire 312that is threaded through a hole in the collar and then a hole in thebottom of the carriage 15 and up through the bottom of the cart 40. Thewire 312 is eventually bundled in the cable 240 and carries anelectrical signal to the circuitry in the control box. The array of UVLEDs 310 receives its electrical signals from the control box through awire 311 that is also threaded through the hole in the collar and then ahole in the bottom of the carriage 15 and up through the bottom of thecart 40 and eventually bundled in the cable 240.

The lid 61 is raised by lifting the distal side of the lid while theproximal side pivots along its hinges. Chains or wires 85 are connectedat one of their ends to the bottom surface 61B of the lid 61 and attheir other ends to the back panel of the cart with hooks or othersecurement means. The lid 61 falls back and is supported by the chains85. The bottom surface 61B of the lid 61 includes a gasket 184 aroundits square or rectangular perimeter that seals the bottom surface 61B ofthe lid 61 to the vessel 800 when the lid 61 is closed.

As shown in FIG. 4A, the lid 61 can have a substantially circular crown350 projecting vertically from its upper surface 340. This crown is inlieu of the collar 300 shown in FIGS. 3A and 4B. The array of UV LEDs310 is coupled to the inside surface of the crown 350, as is the motiondetector 360. The upper lid is formed by covers 62 and 63. Each of thecovers 62 and 63 can form a corresponding half washer shaped raisedportion 62 and 63. Projecting vertically from the center of each raisedportion 62 and 63 is a half circular wall 67 and 68. When the covers 62and 63 are placed over the lid, the washer shaped raised portions 62 and63 join to form a raised washer shaped portion that fits over thecircular crown 350 to form a substantial seal between the outer wall ofthe crown 350 and the inner wall of the washer shaped raised portion.The outer wall of the crown 350 can include a gasket (not shown) toreinforce the seal. The half circular walls 67 and 68 also join to forma cylinder with an opening 169 in the center that is concentric with andopen to the opening 161 of the lid 61.

An oxygen inlet port 77 on the washer shaped raised portion 62 (oralternatively on washer shaped raised portion 63) receives a hose (notshown) connected to an oxygen source, such as an oxygen tank or acentral oxygen source in a hospital. The oxygen inlet port 77 caninclude a fitting (not shown) to sealingly secure the hose to the coverraised portion 62. The raised portion 62 includes a vapor inlet port 72that receives the hose 70 (shown in FIG. 1). The vapor inlet port 72 caninclude a fitting 73 (shown in FIG. 1) to sealingly secure the hose 70to the vapor inlet port 72.

There are only two components of the wound treatment system 10 that makephysical contact with the patient's skin: a liner or bag 100 (as shownin FIGS. 3A and 4B) into which the patient's limb is placed; and a foamcuff 90 (as shown in FIGS. 3B and 4A), which is placed around thepatient's limb.

The liner 100 forms a treatment zone around the wound and makes contactwith the open wound. Therefore, it is preferable that the liner 100 bebiocompatible and sterile. The liner 100 can be discarded or sterilizedafter each use and/or replaced with a new or sterilized liner 100.

The material from which the liner 100 is made can be any strongsubstantially gas impermeable material. Extruded flexible plastic filmmaterial, such as polyethylene (hdpe, ldpe, lldpe, polyprolene, etc,),polyurethane ether or ester open cell foam (e.g., United States PlasticsCorp. Stock No. 47154), polyethylene terephthalate, polyvinyl chloride,or ethylene/polyvinyl copolymer sheet stock, and vapor proof treatedfabric, such as nylon, are suitable. The material can be punctureresistant and transparent. The flexible sheet material can have avariety of shapes. It can be a single layer, such as a bag to surround alimb, or have multiple layers. The bag or liner 100 may also be co ortri axially oriented.

The term “substantially gas impermeable”, as used herein with respect tothe sheet material, means gas impermeable to the extent needed toprevent excessive gas escape from the treatment zone through the sheetmaterial. Total gas impermeability seldom is needed, particularly forcontinuous flow treatment devices. However, generally highimpermeability is desirable for static treatment devices.

The perimeter of the opening of the liner 100 can have an adhesive stripwith a removable backing. The backing can be removed and the perimeterof the lining can be substantially sealed against the crown 350 (or thecollar 300), thus forming a sealed connection between the perimeter ofthe opening of the liner 100 and the lid 61. Alternatively, the liner100 can be taped to the crown 350 (or the collar 300) to form asubstantial seal between the lid 61 and the liner 100.

In one embodiment, the liner 100 includes a pressure release valve 105built into it. The design of the pressure release valve 105 is notcritical. Many different types are suitable. For example, the valve 105can be a ball valve or a baffle valve such as a flap or butterfly bafflevalve. Other valves are equally suitable, so long as they are capable ofaccurately setting the maximum release pressure and are inexpensive andso discardable. If desired the adjustable valve 105 can be calibrated toshow the pressure setting. In one embodiment, the maximum releasepressure can be set at 22 mm of mercury so that the pressure inside theliner 100 never surpasses that amount of pressure. The valve body can bemade of any rigid plastic, although metals such as stainless steel canbe used also. The spring can be steel or plastic. Very inexpensivecompletely plastic valves can be used as well.

The pressure release valves 105 integrated with the liner 100 areinexpensive yet reliably accurate, within the preferred accuracy ranges.If desired, they can be removed from a used liner 100 and reused on newliners. Using a valve that is in communication with the treatment zoneand not with the gas supply eliminates the need for a separate pressurecontrol mechanism between the chamber 810 and the oxygen source. Thechamber 810 can be connected directly to a gas or oxygen tank or ahospital gas supply line.

With any of the embodiments described herein, a foam cuff 90, as shownin FIG. 3B, is placed around the patient's limb and insertedconcentrically with the cylinder formed by the half circular walls 67and 68. The foam cuff 90 can be disjoined so that it can be opened andplaced around a limb. The foam cuff 90 can be made of a biocompatibleopen cell material that is compressible and resilient and forms asubstantial seal or baffle between the patient's limb and the cylinderformed by the walls 67 and 68. The open cell configuration preventsrapid fluid leakage through the cuff, but does allow for some fluidleakage at pressures approaching 22 mm of mercury, thus acting as abaffle. The pressure inside the treatment zone should not reach 22 mm ofmercury, and the fluid leakage through the foam cuff 90 as the pressureinside the treatment zone increases will prevent pressures from buildingup beyond that level. Thus, with the use of an open cell material in thefoam cuff 90, a pressure release valve 105 in the liner 100 may not benecessary. The foam cuff 90 can also include a backing on its outernon-skin contacting surface that can be peeled away, exposing a stickysurface that sticks to the cylinder. The foam cuff 90 can be made of apolyurethane ester or a natural material.

FIGS. 5-7B show the vessel 800 in which the patient's wound is treated.The vessel 800 sits inside of the rigid plastic carriage 15 shown inFIG. 1. As shown in FIGS. 5 and 6A, the vessel 800 is formed byinserting chamber 810 into tank 830. The outer dimensions of the chamber810 are slightly smaller than the inner dimensions of the tank 830 sothat the chamber 810 is nested securely within the tank 830. The onlydimension of the tank 830 that is substantially different from thechamber 810 is that the tank 830 is several inches deeper than thechamber 810. This provides for extra room at the bottom of the tank 830for the audio transducer or speaker 870 connected to the bottom of thechamber 810, so that when the chamber 810 is placed in the tank 830, thetop edges 812 and 832 of the chamber 810 and tank 830 are substantiallycoplanar as shown in FIG. 6A.

The tank 830 is made of a molded plastic or metal that is rigid anddurable. As shown in FIGS. 6A and 6B, the tank 830 has a foam platform835 forming an inner bottom surface of the tank 830. The foam platform835 has a circular pipe hole 836 cut into it that receives the audiotransducer or speaker 870. The foam platform 835 has a second pipe hole837 cut into it that is matched up with a hole 838 cut in the bottom ofthe tank 830 to form an outlet port for the water pipe 818 projectingvertically downward from the bottom surface of the chamber 810. Bolts833 projecting vertically downward from the bottom of the tank 830 areused to guide and connect the tank 830 to the carriage 15.

Turning to FIGS. 7A and 7B, chamber 810 is shown in more detail. Thechamber 810 includes a sealing member 813 that surrounds the chamberjust beneath its edge 812. The sealing member 813 forms a substantiallyfluid-tight seal between the chamber 810 and the tank 830. Inside thechamber 810 is an IR board 880 with an array of IR LEDs. The board 880has bolts 881 on its corners that are used to bolt the board 880 to thebottom of the chamber 810. PCB wiring 881 is coupled to the IR board 880and exits from the chamber 810 through hole 882 drilled into the bottomof the chamber 810. The hole 882 can be drilled at a location beneaththe IR board 880 and can be about ¼ inch. Silicone, hot glue, and/orother sealing materials can be used to form a fluid tight seal betweenthe wiring 881 and the hole 882 to seal the chamber 810, hardware, andwires from leaks. The wiring 881 is lead through the pipe hole 837 inthe tank 830 and connects with a connection to the control box.

The IR board 880 includes IR LEDs arranged in a pattern on a square orrectangular board. The IR LEDs can emit energy at infrared frequenciesof between about 700 nm and 50,000 nm. The IR board 880 can becontrolled by the control panel to adjust the frequency. In oneembodiment, the IR LEDs deliver about 2000 mW of infrared light at about810 nm. In one embodiment, the IR board 880 can also generate about 1.2W of Red light at about 660 nm for a combined total light output of 1911mW. For example, the IR board 880 can be a Thor DDII IR Lamp System.

Turning to FIG. 7A, a hole is drilled through the bottom of the chamber810, and the water pipe 818 is inserted through the hole, projectingvertically downward through the hole and out the bottom of the chamber810. A tub seal pipe coupling 819 is used to form a fluid tight sealbetween the pipe 818 and the hole through which it is inserted throughthe chamber 810. The water pipe 818 is open at both ends to allow waterto flow in and out of the chamber 810 when the chamber 810 is connectedto the reservoir 600 through a water hose.

As shown in FIGS. 7A and 7B, coupled to the outside of the chamber atthe bottom of the chamber 810 is an audio transducer or speaker 870. Thespeaker 870 is bolted to the bottom of the chamber 810. Transducer wires876 are connected to the speaker 870 and, like the IR wiring, arethreaded through the pipe hole 837 in the tank 830 to form a connectionwith the control box. As shown in FIGS. 5 and 6A, a rigid plastic ormetal collar 890 with a hole 892 is placed around the speaker 870 toprotect the speaker 870. The speaker 870 emits energy at a low frequencysound wave, of between about 1 Hz and about 1000 Hz. In one embodiment,the speaker emits energy at about 60 Hz. This causes a therapeuticvibration on the chamber 830 and a massaging effect on the patient'slimb.

In one embodiment the foam platform 835 is a premolded piece that isinserted into the bottom of the tank 810, and the chamber 810 is placedon top of the foam 835. In another embodiment, a hardening foam gel ispoured into the bottom of the tank 810 to a predetermined depth, and thechamber 810 with speaker 870 and collar 890 are quickly placed into thetank 810. The foam gel hardens around the pipe 838 and wires 881 and876, the collar 890, and the bottom of the chamber 810. The tank 830 isultimately bolted to the rigid plastic carriage 15.

Now turning to FIGS. 8A and 8B, the components of the wound treatmentsystem 10 that are housed in the cart 40 are shown. Both FIGS. 8A and 8Bare front views of the cart 40 looking at the cart 40 from the directionof viewing the control panel 30. FIG. 8A shows the components with thehumidifier 400 removed so that the water pump 500 is visible. FIG. 8Bshows the components with the humidifier 400 in its normal positionblocking a view of the pump 500, which sits behind the humidifier 400.

As shown in FIG. 8A, a warm water reservoir 600 rests on a shelf 43 atthe bottom of the cart 40. A first hose 510 is connected to the waterpump 500 through fitting 512. The other end of the hose 510 is securedto a hose fitting 630 (shown in FIG. 9B) laterally projecting from thereservoir 600 so that the hose is in fluid communication with the insideof the reservoir 600. A second hose 520 is connected to the water pump500 through fitting 522. The other end of hose 520 is connected to thewater pipe 818 projecting vertically from the bottom of the vessel 800so that the hose 520 is in fluid communication with the inside of thechamber 810. Cables 510 electrically couple the water pump to thecontrol box. The reservoir 600 has a rigid lid 610 that can, be removedto expose the inside of the reservoir and fill it with water.

Turning to FIGS. 9A and 9B, the reservoir 600 is shown in more detail.The reservoir 600 includes two float switches 640 and 650. An upperfloat switch 640 is used to determine when the reservoir 600 is full anda lower float switch 650 is used to determine when the reservoir 600 isempty. Switch 640 has a lead 642 that is electrically connected toterminal block 660 with wire 645. Switch 650 has a lead 652 that iselectrically connected to terminal block 660 with wire 655. Terminalblock 660 is electrically connected to the pump with wires 670. Thespacing between the switches 640 and 650 determines the amount of waterthat will be pumped into the chamber 830 when the system 10 is activatedand the pump function is operating. The switches 640 and 650 arearranged so that the optimal amount of water is pumped into the chamber830. If too much water is pumped into the chamber, the lid 61 candislodge causing the chamber 830 to leak. If there isn't enough water,the patient's limb will not be warmed enough. In one embodiment, aboutfive gallons of water is pumped from the reservoir 600 to the chamber830. When the pump function is activated, the pump begins to pump water500 out of the reservoir 600 through fitting 660. When the water levelreaches the lower switch 650 and the floating arm 653 of the switch 650begins to dip fall, an electrical signal is transmitted to the pump 500through wires 670, and the pump 500 automatically shuts off. When thedrain function is activated, the pump 500 begins to pump in reverse,draining the water from the chamber 830 and back into the reservoir 600.When the water in the reservoir reaches the upper switch 650 and thefloating arm 643 of the switch 640 begins to rise, an electrical signalis transmitted to the pump 500 through wires 670, and the pumpautomatically turns off.

In one embodiment, the water is kept at an optimal temperature with aportable heating unit 680 that is adjustable between a range of about70.degree. F. and about 90.degree. F. In another embodiment, a moresophisticated heating unit is used (not shown) that is electricallycoupled to the control box and can be controlled with a thermostat inthe control panel 30.

Turning back to FIG. 8B, the humidifier unit 400 sits atop the lid 610of the reservoir 600. The humidifier has a removable lid 410 that can beremoved to fill the reservoir of the humidifier 400 with water and anantibacterial agent, such as ionic silver, hydrogen peroxide,bacitracin, betadine, or isopropyl alcohol. In one embodiment,adiabatically humidified 1% hydrogen peroxide/silver solution is used,but other FDA approved topical antibacterial, antibiotic, antisepticsand antimicrobial solutions and agents, such as those described above,may also be used.

The humidifier 400 has a misting unit that constantly produces mist aslong as the humidifier function on the control panel 30 is activated.The misting unit can be an adiabatic temperature controlled humidifieror ultrasonic nebulizer. The humidifier 400 can generate roomtemperature mist or heated mist. It can include a built-in heater (notshown) with an on/off switch and an indicator light that shows that theheater is on and at operating temperature. Warm mist temperature in thebag 100 can reach between about 77.degree. F. and about 82.degree. F. asmeasured with a temperature gauge in the lid assembly. The humidity inthe bag 100 can reach about 89% to about 91% as measured by a humiditygauge. The humidifier has a transducer that generates ultrasonic energyat about 40 kHz to create an adiabatic/humid mist that creates a cloud.Ultrasonic energy from the misting unit is not transmitted to the limb,which is about two feet away from the misting unit. When the valvecontrol unit 50 is opened, the mist travels from the humidifier 400 intothe exit tube 410 and out through the exit port 420 where it enters thevalve control unit 50. From there the mist travels through the tube 70and into the treatment zone formed by the bag 100 surrounding thepatient's limb.

In another aspect of the present invention, the variable hyperoxiatreatment apparatus as shown in FIG. 10, provides at least one treatmentchamber for receiving a body part that separates the electroniccomponents of the apparatus from the oxygen supply and concentrator.Many of the component parts of this apparatus are similar or identicalto those discussed in previous embodiments and aspects. A majority ofthe electrical components of the apparatus are isolated from the oxygensource and the components that deliver oxygen to the treatment chamberand the patient. In particular, the water fill port 975, the medicinefill port 970, the adiabatic humidifier 980, the ultrasound device 982,the humidifier control valve 984, the control panel 962, the temperaturesensor 952, the pressure sensor 950, the humidity sensor 986, the lidsensor 928, the electrical connections to the UV/IR LED arrays 924 arepreferably on one side of the treatment chamber while the oxygen intakeport 946, oxygen control valve 940, oxygen concentrator 942 and oxygendelivery ports 948 are on the other side of the treatment chamber.Alternatively, the oxygen intake port 946, oxygen control valve 940,oxygen concentrator 942 and oxygen delivery ports 948 may be securelyhoused in a separate chamber isolated from electronic components of theapparatus but not separated by the treatment chamber.

Multiple arrays of UV and IR LEDs 942 that irradiate the surface of thebody part are mounted to the chamber. There may be as few as five LEDSone mounted to illuminate the front, one for the back, one for the leftside, one for the right side and one for the base of the body part.Alternatively, there may be arrays 942 of ten to several hundredpositioned similarly to irradiate the entire body part in the treatmentchamber. The array of UV LEDs 942 can deliver 330 W of UVA at about 320nm to about 400 nm. Alternatively, or in addition to, the array of UVLEDs 942 can deliver 330 W of UVB at about 290 nm to about 320 nm.Alternatively, or in addition to, the array of UV LEDs 942 can deliver330 W of UVC at about 100 nm to about 200 nm. In one embodiment, thereare ninety UV LEDs delivering 330 W of UVA at about 374 nm to about 392nm, delivering a total of about 324 mW or 324 W.

The IR board includes IR LEDs 942 arranged in a pattern about thechamber. The IR LEDs 942 can emit energy at infrared frequencies ofbetween about 700 nm and 50,000 nm. The IR LEDs 942 can be controlled bythe control panel 962 to adjust the frequency. In one embodiment, the IRLEDs 942 delivers about 2000 mW of infrared light at about 810 nm. Inone embodiment, the IR LEDs 942 can also generate about 1.2 W of redlight at about 660 nm for a combined total light output of 1911 mW. Forexample, the IR LEDs 942 can be a Thor DDII IR Lamp System. Theprogrammed treatment also sends electrical signals from the control boxto the arrays of UV/IR LEDs 942 through a wire that is also threadedthrough the device and eventually bundled in the cable leading to thecontrol panel 962.

The lid is provided as a two-piece circular collar 926 that forms aperimeter around the opening of the treatment chamber. Sliding apart thetwo pieces of the circular collar 926 opens the lid. The lid alsoincludes a sensor 928 to detect the diameter of the body part that hasbeen inserted through the collar 926. The sensor 928 wire is threadedthrough the device and eventually bundled in the cable leading to thecontrol panel 962. The diameter of the body part is relayed to aprocessor in the control panel 962 that establishes the amount ofhumidified mist and oxygen that will be applied to the body part foreach step of the programmed treatment.

An oxygen inlet port 946 receives a hose (not shown) connected to anoxygen source, such as an oxygen tank or a central oxygen source in ahospital. The oxygen inlet port 946 allows oxygen to flow from thesource to an oxygen flow meter 944 in communication with the oxygenconcentrator 942. The oxygen concentrator 942 and/or oxygen flow meter944 is in communication with the liner 900 through a one-way valve 940allowing control of oxygen to the treatment zone. The oxygenconcentrator 942 and/or oxygen flow meter is also in communication witha cannula or facemask that may be worn by the patient during treatment.The oxygen supply line hose may be sealingly affixed to an inlet port946 on the side of the apparatus (not shown) which is directly connectedto the oxygen flow meter 944 and/or oxygen concentrator 942.

The liner 900 forms a treatment zone around the wound and makes contactwith the open wound. Therefore, it is preferable that the liner 900 bebiocompatible and sterile. The liner 900 can be discarded or sterilizedafter each use and/or replaced with a new or sterilized liner 900. Thematerial from which the liner 900 is made can be any strongsubstantially gas impermeable material. Extruded flexible plastic filmmaterial, such as polyethylene (hdpe, ldpe, lldpe, polyprolene, etc,),polyurethane ether or ester open cell foam (e.g., United States PlasticsCorp. Stock No. 47154), polyethylene terephthalate, polyvinyl chloride,or ethylene/polyvinyl copolymer sheet stock, and vapor proof treatedfabric, such as nylon, are suitable. The material can be punctureresistant and transparent. The liner 900 also has at least two one-wayinlet valves 940 at or about its base for receiving mist/medicated mistfrom the humidifier 980 and oxygen from the oxygen flow meter 944 and/oroxygen concentrator 942. The design of the one-way valves 940 is notcritical. A variety of different types may be utilized. The liner 900may also have an outlet port (not shown) that may be utilized forallowing replacement of agents in the treatment zone with fresh or otheragents during the programmed treatment.

The perimeter of the opening of the liner 900 can have an adhesive stripwith a removable backing. The backing is removed and the perimeter ofthe lining substantially is sealed against the two-pieces of the collar926 thus forming a sealed connection between the perimeter of theopening of the liner 900 and the lid. Alternatively, the liner 900 mayhave a foam rim or cuff 916 about the opening with a drawstring. Thefoam rim 916 provides a comfortable seal around the body part beingtreated when the drawstring is tightened.

The liner 900 may also have a pressure release valve 914. The design ofthe pressure release valve 914 is not critical. Many different types aresuitable. For example, the valve 914 can be a ball valve or a bafflevalve such as a flap or butterfly baffle valve. Other valves are equallysuitable, so long as they are capable of accurately setting the maximumrelease pressure. If desired the adjustable valve can be calibrated toshow the pressure setting. In one embodiment, the maximum releasepressure can be set at 22 mm Hg so that the pressure inside the liner900 never surpasses that amount of pressure. The valve body ispreferably made of any in expensive rigid plastic.

Coupled to the bottom of the chamber on its outside surface is an audiotransducer or speaker 960. Transducer wires are connected to the speakerand threaded through the apparatus to form a connection with the controlpanel 962. A rigid plastic or metal collar with a hole is placed aroundthe speaker 960 to protect the speaker 960 during use. The speaker 960emits energy at a low frequency sound wave, of between about 1 Hz andabout 1000 Hz. In one embodiment, the speaker 960 emits energy at about60 Hz. This causes a therapeutic vibration on the chamber and amassaging effect on the patient's body part.

The components of the variable hyperoxia treatment apparatus are housedin a cart. A warm water reservoir 995 is contained at the bottom of thecart. A first hose is connected to the water pump 990 and the other endof the hose is secured and in fluid communication with the inside of theone or more chambers. A second hose (not shown) is connected to thewater pump 990 and the other end of hose can be connected to a wastecontainer or drain. Cables electrically couple the water pump to thecontrol box. The reservoir 995 provides an opening that allows thereservoir to be filled with water.

The water may be kept at an optimal temperature with a portable heatingunit (not shown) that is adjustable between a range of about 70° F. toabout 90° F. Alternatively a heating unit within the apparatus may beused (not shown) that is electrically coupled to the control panel 962and can be controlled with a thermostat in the control panel 962.

The humidifier 980 is positioned above the warm water reservoir 995. Thehumidifier 980 is in fluid communication with a water reservoir 975 thathas a removable lid to enable filling with fluid and/or medication. Amedication reservoir 970 for receiving medications and/or medicationdosage is in fluid communication with the humidifier 980 so that it maybe mixed with fluid to create an adiabatic vapor or mist for treatment.

The humidifier 980 produces mist when the humidifier function on thecontrol panel 962 is activated. The misting unit can be an adiabatictemperature controlled humidifier 980 or ultrasonic nebulizer 982. Thehumidifier 980 can generate room temperature mist or heated mist. Thehumidifier may further comprise a temperature controller 954 with anon/off switch and an indicator light that shows when the temperaturecontroller 954 is on and at operating temperature. When the humidifiercontrol valve 984 to the humidifier 980 is opened, the mist travels fromthe humidifier 980 into the treatment zone through a one-way valve inthe liner 900. Warm mist temperature in the liner 900 can reach betweenabout 77° F. to about 82° F. as measured by a temperature sensor. Thehumidity in the liner 900 can reach about 89% to about 91% as measuredby a humidity sensor 986. The humidifier 980 has a transducer thatgenerates ultrasonic energy in the ultrasonic nebulizer 982 at about 40kHz to create an adiabatic/humid mist. Ultrasonic energy from themisting unit is not transmitted to the limb.

In another embodiment, the oxygen flow meter 944 and concentrator 942and humidifier 980 are also in fluid communication with an outlet portthat is in fluid communication 916 with a treatment chamber remote tothe cart. The treatment chamber 910/914 (FIG. 11) comprises a pre-moldedform adapted to encompass a non-limb body part such as a scalp, a thighor the back. The chamber 910/914 is composed of a semi-rigid polymerhaving a cushioned perimeter edge for sealingly engaging the body part.Its configuration will depend on the area being treated. For example, ahalf domed shape may be desired for treating a particular location onthe back while a helmet shaped chamber would be desirable for treatingthe scalp. The chamber may have at least two inlet ports, one for thehumidified mist from the humidifier 980 and one for oxygen from theoxygen flow meter 944 and/or oxygen concentrator 942. There may be anadditional outlet port (not shown) to allow for replacing the existingagents in the chamber with new or other agents. The treatment chamber910/914 may further comprise UV/IR LEDs for illuminating the treatmentarea. The UV/IR LEDs are in electrical communication with the controlpanel 962. This electrical communication line may be affixed to orintegrated within tubing 912 and has a connector near adapters 916 forconnecting to the control panel 962. A disposable or autoclavable liner900 having at least two one-way ports at 940 and 984 for receivinghumidified mist and oxygen lines the chamber. The liner 900 may alsohave a pressure release valve 914. The perimeter edge of the liner 900may have adhesive for affixing the liner 900 to the rim of the chamberbefore use.

The disclosure set forth above is provided to give those of ordinaryskill in the art a complete disclosure and description of how to makeand use embodiments of the compositions and methods of the presentinvention, and are not intended to limit the scope of what the inventorsregard as their invention. Modifications of the above-described modes(for carrying out the invention that are obvious to persons of skill inthe art) are intended to be within the scope of the following claims.All publications, patents, and patent applications cited in thisspecification are incorporated herein by reference in their entirety asif each such publication, patent or patent application were specificallyand individually indicated to be incorporated herein by reference.

The invention claimed is:
 1. A variable hyperoxia treatment apparatus,comprising: one or more treatment chambers being sized to receive ahuman body part; a removable and substantially gas impermeable linerthat lines each of said chambers and is adapted to form a treatment zonearound said human body part; a mixture tank that holds a humidifyingagent and a medicinal filling port for receiving medications to be mixedwith said humidifying agent; and an oxygen concentrator that has an O₂receiving port for receiving oxygen from an oxygen source and an O₂dispensing port, wherein said mixture tank and said oxygen concentratorare in communication with said gas impermeable liner within saidtreatment chambers, wherein said one or more treatment chambers have aninlet port for receiving fluid and an outlet port for dispensing saidfluid, and wherein one or more electric components, comprising a controlpanel configured to allow control of the variable hyperoxia treatmentapparatus and a humidifier control valve, and said mixture tank arepositioned on a first side of said one or more treatment chambers andsaid oxygen concentrator and oxygen receiving port are positioned on asecond side of said one or more treatment chambers, the second sideopposite the first side, and the one or more treatment chamberspositioned between the one or more electric components on the first sideand the oxygen concentrator and oxygen receiving port on the secondside.
 2. The variable hyperoxia treatment apparatus according to claim1, further comprising a speaker; wherein said speaker configured todeliver low frequency sound waves to said one or more chambers whenwater is introduced into said one or more chambers.
 3. The variablehyperoxia treatment apparatus according to claim 1, wherein said linerfurther comprises a pressure release valve fluidly connecting saidtreatment zone to said one or more chambers and/or a one-way valve influid connection with said mixture tank and/or a one-way valve in gastight connection with said oxygen concentrator.
 4. The variablehyperoxia treatment apparatus according to claim 1, further comprising acuff, wherein said cuff is removably coupled to said opening of said oneor more treatment chambers and sized to sealingly engage a human bodypart when said human body part is engaged by said one or more treatmentchambers.
 5. The variable hyperoxia treatment apparatus according toclaim 1, further comprising a temperature sensor, a humidity sensorand/or a pressure sensor in fluid communication with said treatmentzone.
 6. The variable hyperoxia treatment apparatus according to claim1, further comprising an oxygen regulator valve and/or a nasal cannulaand/or facemask in communication with said oxygen concentrator foradministering oxygen to an individual during treatment.
 7. The variablehyperoxia treatment apparatus according to claim 1, further comprisingultraviolet and/or infrared light emitting diodes to provideillumination to the surface of said human body part within saidtreatment zone.
 8. The variable hyperoxia therapy treatment systemaccording to claim 1, wherein the one or more electric componentsfurther comprise an adiabatic humidifier configured to humidify thehumidifying agent.
 9. A variable hyperoxia therapy treatment system,comprising: one or more treatment chambers being sized to receive ahuman body part, said one or more treatment chambers each having atleast one opening; a removable and substantially gas impermeable linerthat lines each of said chambers and forms a treatment zone around saidhuman body part; a humidifier configured to humidify a solution of waterthat may include one or more medications, said humidifier in fluidcommunication with said treatment zone; an O₂ source in fluidcommunication with the treatment zone; and a control panel, wherein oneor more electric components comprising said humidifier and said controlpanel are positioned on a first side of said one or more treatmentchambers and said oxygen source is positioned on a second side of sideone or more treatment chambers, the second side opposite the first side,and wherein said one or more treatment chambers are positioned betweenthe first side and the second side.
 10. The variable hyperoxia therapytreatment system according to claim 9, wherein at least one of said oneor more treatment chambers may be affixed securely to a human body partor wherein a human body part may be inserted into said one or morechambers for treatment.
 11. The variable hyperoxia therapy treatmentsystem according to claim 9, wherein said liner further comprises aone-way valve in fluid connection with said humidifier and/or a one-wayvalve in gas tight connection with said oxygen source.
 12. The variablehyperoxia therapy treatment system according to claim 9, furthercomprising a source of fluid, said source in fluid communication withsaid one or more chambers and/or a pump configured to pump fluid out ofsaid one or more chambers.
 13. The variable hyperoxia therapy treatmentsystem according to claim 9, wherein the control panel comprises an autocontrol switch configured to permit automatic operation of said systemaccording to a predetermined regimen or plurality of predeterminedregimens.
 14. The variable hyperoxia therapy treatment system accordingto claim 9, further comprising a foam cuff adapted to form a seal aboutsaid human body part and said opening of said one or more chambers. 15.The variable hyperoxia therapy treatment system according to claim 14,further comprising a sensor in communication with said foam cuff whereinthe position of said foam cuff when fitted about said human body partestablishes a volume range of humidified solution containing one or moremedications to be dispensed into said liner for treatment of said bodypart.
 16. The variable hyperoxia therapy treatment system according toclaim 9, further comprising an oximeter in electrical communication withcontrol circuitry integrated with said control panel.
 17. The variablehyperoxia therapy treatment system according to claim 9, furthercomprising a pressure sensor and/or a humidity sensor in communicationwith said treatment zone.
 18. The variable hyperoxia therapy treatmentsystem according to claim 9, further comprising ultraviolet and/orinfrared light emitting diodes to provide illumination to the surface ofsaid human body part within said treatment zone.
 19. The variablehyperoxia treatment apparatus according to claim 9, further comprising anasal cannula or facemask in communication with said oxygen source foradministering oxygen to an individual during treatment.
 20. The variablehyperoxia therapy treatment system according to claim 9, furthercomprising an O₂ concentrator, a wireless transmitter adapted totransmit data, and/or a barcode data reader.